Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04488081 · ClinicalTrials.gov registry record · Phase 2
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
A Phase 2 study of COVID-19, sponsored by QuantumLeap Healthcare Collaborative.
- Active
- Registry status
- Phase 2
- Development phase
- 1,500
- Enrollment target
- 20
- Study locations
NCT04488081: Active Phase 2 study of COVID-19, sponsored by QuantumLeap Healthcare Collaborative.
NCT04488081 is a Phase 2 study of COVID-19 that is active but no longer recruiting, run by QuantumLeap Healthcare Collaborative. The registered enrollment target is 1,500 participants, below the 38,460-participant average among 298 other COVID-19 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04488081, a Phase 2 study of COVID-19, is active but no longer recruiting, sponsored by QuantumLeap Healthcare Collaborative.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.
Primary Outcome
Time to reach a durable COVID-19 level 4 or less or discharge at COVID-level 4 or lower (except for discharge to another hospital), and time to death (mortality). Data will be analyzed for 3 groups: * All * COVID-19 level 6/7 (those intubated immediately) * COVID-19 level 5 (high flow oxygen to start) World Health Organization 9-point ordinal scale: 0\. No clinical or virologic evidence of infection 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activi
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Remdesivir
- DRUG Icatibant
- DRUG Imatinib Mesylate
- DRUG Cenicriviroc
Study Locations (20)
California
- UC Davis Medical Center - Davis
- UC Irvine Medical Center - Irvine
- Long Beach Memorial Medical Center - Long Beach
- Kaiser LAMC - Los Angeles
- University of Southern California - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- University of California San Francisco (UCSF) - San Francisco
Connecticut
- Yale Cancer Center - New Haven
- Stamford Health - Stamford
Florida
- University of Miami - Coral Gables
- University of Florida - Gainesville
Michigan
- University of Michigan - Ann Arbor
- Corewell Health - Grand Rapids
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- University of Colorado - Aurora
District of Columbia
- Georgetown University - Washington D.C.
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2030-07-31 |
| Phase | Phase 2 |
What the registry record for NCT04488081 still lists
NCT04488081 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 38,460-participant average among 298 other COVID-19 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT04488081 names 20 study sites across 11 states, led by California, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT04488081 about?
NCT04488081 is a clinical study titled "I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients". The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as...
What is the current status of trial NCT04488081?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,500 participants. The study started on 2020-07-31. Estimated completion is 2030-07-31.
What conditions does trial NCT04488081 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04488081?
The interventions under investigation include: Dexamethasone (DRUG), Remdesivir (DRUG), Icatibant (DRUG), Imatinib Mesylate (DRUG), Cenicriviroc (DRUG).
Who is sponsoring clinical trial NCT04488081?
This trial is sponsored by QuantumLeap Healthcare Collaborative, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04488081 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04488081's enrollment target sits among peer trials
1,500 53rd of 298 higher than 244 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Arginine Replacement Therapy in COVID-19
RECRUITING · Phase 2
-
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
RECRUITING · Phase 2
-
A Nasal Treatment for COVID-19
RECRUITING · Phase 2
-
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
RECRUITING · Phase 2
-
Mitoquinone/Mitoquinol Mesylate as Oral and Safe Postexposure Prophylaxis for Covid-19
RECRUITING · Phase 2
-
Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00178724 · 1,500 participants
Spinal Cord Injury Registry - North American Clinical Trials Network
- NCT00951366 · 1,500 participants
Preterm Lung Patient Registry
- NCT01050504 · 1,500 participants
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
- NCT02071134 · 1,500 participants
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI